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    Clinical Trial Results:
    Bictegravir/FTC/TAF for the treatment of primary HIV infection (BIC-PHI trial).

    Summary
    EudraCT number
    		 2020-000601-89
    Trial protocol
    		 ES  
    Global end of trial date
    29 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Sep 2025
    First version publication date
    13 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BIC-PHI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04483674
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clinic per a la Recerca Biomèdica
    Sponsor organisation address
    Villarroel, 170, Barcelona, Spain,
    Public contact
    AnaCcruceta, Clinical Trial unit (CTU), acruceta@recerca.clinic.cat
    Scientific contact
    AnaCcruceta, Clinical Trial unit (CTU), acruceta@recerca.clinic.cat
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Proportion of patients with rapid ART initiation with Bictegravir/FTC/TAF regimen who reached a VL <50 copies at 48 weeks (FDA snapshot algorithm) in the intention-to-treat (ITT) population.
    Protection of trial subjects
    Trial subjects are protected under the Declaration of Helsinki, GCP, and local laws. Informed consent is required, confidentiality is ensured, and participants may withdraw at any time. Ethics committees oversee the study’s conduct.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    64
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 66 subjects screened; 64 enrolled. Exclusion criteria: recent PrEP use, complete seroconversion, active HCV. ART initiated within 72h of diagnosis to ensure early-stage PHI inclusion and assess impact on viral reservoir.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BIC/FTC/TAF
    Arm description
    		 Single-arm: BIC/FTC/TAF regimen (Treatment with bictegravir/emtricitabine/tenofovir alafenamide).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bictegravir/emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    BIKTARVY®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BIKTARVY® is a three-drug fixed dose combination product containing 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of BIKTARVY is one tablet taken orally once daily with or without food in adults for 48weeks.

    Number of subjects in period 1
    		BIC/FTC/TAF
    Started
    64
    Completed
    56
    Not completed
    8
         Physician decision
    2
         Lost to follow-up
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 64 64
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 32 (26 to 41) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 60 60
    Geographical origin
    Units: Subjects
        Europe
    		 37 37
        Latin-America
    		 22 22
        Other
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    BIC/FTC/TAF
    Reporting group description
    		 Single-arm: BIC/FTC/TAF regimen (Treatment with bictegravir/emtricitabine/tenofovir alafenamide).

    Primary: Proportion of patients with rapid ART initiation with Bictegravir/FTC/TAF regimen who reached a VL <50 copies at 48 weeks (FDA snapshot algorith) in the intention-to-treat (ITT) population.

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    End point title
    		 Proportion of patients with rapid ART initiation with Bictegravir/FTC/TAF regimen who reached a VL <50 copies at 48 weeks (FDA snapshot algorith) in the intention-to-treat (ITT) population. [1]
    End point description
    End point type
    Primary
    End point timeframe
    48 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint—proportion of patients with VL <50 copies/mL at 48 weeks (FDA snapshot, ITT)—is descriptive in nature and aligned with standard virological efficacy benchmarks in HIV trials. Given the single-arm design, no formal hypothesis testing was planned. The endpoint provides clinically meaningful data without requiring inferential statistics.
    End point values
    		 BIC/FTC/TAF
    Number of subjects analysed
    64
    Units: copies/mL
    52
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of treatment until 48 weeks post-initiation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    BIC/FTC/TAF
    Reporting group description
    		 -

    Serious adverse events
    		 BIC/FTC/TAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 64 (6.25%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Removal of a rectal foreign body
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Worsening of a known cardiopathy
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Perianal abscess
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BIC/FTC/TAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 64 (65.63%)
    Gastrointestinal disorders
    Diarrhea, etc
         subjects affected / exposed
    10 / 64 (15.63%)
         occurrences all number
    10
    Skin and subcutaneous tissue disorders
    Dermatologic
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    6
    Psychiatric disorders
    Insomnia, headache, anxiety and depression
         subjects affected / exposed
    10 / 64 (15.63%)
         occurrences all number
    10
    Infections and infestations
    Mostly uupper respiratory viral infections and sexually transmitted infections
         subjects affected / exposed
    28 / 64 (43.75%)
         occurrences all number
    28

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2022
    Extension of the recruitment period by 12 additional months. Rationale: 1- Increased use of pre-exposure prophylaxis (PrEP), which reduced the number of eligible participants. 2- Decrease in patient availability due to the COVID-19 pandemic.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Recruitment was extended due to increased PrEP use and COVID-19 impact. The single-arm design, limited early-stage cases, and exclusion of PrEP users may affect generalizability and statistical power.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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